MAUDE Adverse Event Report: ARTHREX, INC. HUMSUTRPLT DEPTH GD DIST.CORT.SCRW; DEPTH GAUGE

Model Number	HUMSUTRPLT DEPTH GD DIST.CORT.SCRW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a facility representative reported via (b)(4) that an ar-14100g humeral sutureplate depth guide broke off in the canal of the patient and could not be removed via a proximal humerus.The procedure was completed successfully.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces, misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: HUMSUTRPLT DEPTH GD DIST.CORT.SCRW
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23004051
• Report Number: 1220246-2025-03766
• Device Sequence Number: 9413122
• Product Code: HTJ
• UDI-Device Identifier: 00888867016804
• UDI-Public: 00888867016804
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HUMSUTRPLT DEPTH GD DIST.CORT.SCRW
• Device Catalogue Number: AR-14100G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown